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Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy With Selective Radiotherapy Use in Patients With Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging
Phase II, Multicenter, Open-label, Non-randomized Study of Neoadjuvant Chemotherapy (CAPECITABINE-OXALIPLATIN + BEVACIZUMAB) with Selective Radiotherapy and Chemotherapy with CAPECITABINE Use in Patients with Intermediate-Risk Cancer of the Rectum Defined by Magnetic Resonance Imaging.
Details
| Lead sponsor | Grupo Espanol Multidisciplinario del Cancer Digestivo |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 46 |
| Start date | 2009-03 |
| Completion | 2013-06 |
Conditions
- Rectum Cancer
Interventions
- Capecitabine
- Oxaliplatin
- Bevacizumab
- Radiotherapy
- Capecitabine during all Radiotherapy period
- Total Mesorectal Excision (TME)
Primary outcomes
- Efficacy of XELOX/BVZ neoadjuvant therapy with selective radiotherapy use in patients with locally advanced tumors of the rectum, measured in terms of the proportion of responders (PCR + CCR), according to RECIST criteria — Until the end of study
Countries
Spain